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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ear, nose, and throat image analyzer
Definition An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.
Product CodeSHL
Regulation Number 874.4775
Device Class 2


Premarket Reviews
ManufacturerDecision
TYTO CARE , LTD.
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